Medical data processing

ABSTRACT

A test tube bearing a label for receiving identifying marks is keyed into a label marking unit in the presence of the patient. Unique patient identification information is transcribed from his charge plate or wrist bracelet. Specimen description information and processing directions generated by keyboard, automatic modules, or auxiliary cards are also encoded on the label. Such cards may also receive the identification information. The label is decoded in keyed reading units in the laboratory and the indicated procedures performed. The identification information is read at process junctures and transcribed automatically to additional aliquot containers as required to maintain positive identification of the specimen.

United States Patent Sedickson et a1.

58 Field Inventors:

Assignee:

Filed:

Appl.

tin J. Rubin, Chevy Chase, Md.

American Science & Engineering, Inc.,

Cambridge, Mass.

Aug. 28, 1969 US. Cl. ..128/2 R, 73/423 A, 128/2 G,

A6lb 10/00 ofSearch ..l28/2,2 R,2G,2F;

References Cited UNITED STATES PATENTS Young ..73/423 A Conrad Whitehead et al.. Engelhardt et al..

15] 3,656,473 [451 Apr. 18, 1972 Primary Examiner-Richard A. Gaudet Assistant Examiner-Kyle L. Howell AttorneyCharles Hieken [5 7] ABSTRACT A test tube bearing a label for receiving identifying marks is keyed into a label marking unit in the presence of the patient. Unique patient identification information is transcribed from his charge plate or wrist bracelet. Specimen description information and processing directions generated by keyboard, automatic modules, or auxiliary cards are also encoded on the label. Such cards may also receive the identification information. The label is decoded in keyed reading units in the laboratory and the indicated procedures perfonned. The identification information is read at process junctures and transcribed automatically to additional aliquot containers as required to maintain positive identification of the specimen.

8 Claims, 5 Drawing Figures SHEET 10F 2 INVENTORS R SODI C KS ON ATTORNEYS RTIN RUBIN STE PATENTEDAPR 18 I972 HOSPI 18% WARD ADMITTING ROOM 7 mmOCmmd 0 PORTABLE LABEL ENCODER F l G. 2

FIG.

PATENTEDAPR 18 I972 SHEET 2 UF 2 ORIG NA L BLANK 00 N TAINERS LABELED SAMPLE CONTAINER WITH UNMARICED LABELS LABEL 8\ ALIQUOT TRANSFER UNI T ORIGINAL SAMPLE LABELED CONTAINER .ALIQUOT CONTAINER OUT FIG. 4

ENTO R s CKSO N R N M ATTORNEYS MEDICAL DATA PROCESSING The present invention relates in general to the processing of medical data and more particularly concerns apparatus and techniques for insuring positive identification of a sample throughout the processing system in which test procedures are performed to aid in medical diagnosis of the patients ailment and the monitoring of his response to therapy. The invention facilitates accurately identifying a specimen-bearing container associated with a particular patient with a minimum of error.

Considerable effort has been devoted to increasing the speed and efficiency of hospital clinical laboratories by using computerized data retrieval and manipulation systems and by coupling computers to existing automated analysis instruments. The overall time for processing collected samples and the burden of routine record-keeping functions once in the laboratory has been materially reduced. Despite these advances, serious problems remain. To date the sample labeling problem has not been adequately solved, with all known manual and automated technique subject to a numerous variety of possible circumstances in which an accurately analyzed sample can be associated with the wrong patient. For example, blood may be drawn from the wrong patient, a sample tube may be wrongly marked, the label may be accidentally transposed during transit or processing, or the label may be misinterpreted. Accordingly, it is an important object of this invention to minimize the opportunities for such errors by the use of a specially prepared damage resistant permanently attached label, and by performing the labeling operation substantially at the time and place the specimen is withdrawn from a patient in a manner that facilitates automatic processing of the specimen and association of the test results with the patient.

SUMMARY OF THE INVENTION According to the invention, there is a label imprinter adapted to receive a specimen container with a permanently attached encodable label thereon and at least a patient identifying card or wrist bracelet kept with the patient so that a nurse or technician may insert the card or bracelet and cause the patient identification data to be directly impressed on the specimen container label, preferably with other indicia further identifying the specimen such as the nature of the specimen, the date and/or time taken.

The label is not detachable from the tube nor subject to damage or alteration under normal hospital conditions. The information is transcribed onto the. tube in the form of digitally encoded dots or other kinds of markings and may thus be either numeric or alphanumeric in content. These marks can both be written and read by machine and the information which they carry is therefore in a form compatible with but not limited to automatic data processing systems.

The unique patient identification information is transferred from coded holes or marks on the patients hospital charge plate or from a similarly prepared wrist bracelet when these are inserted into the aforementioned marking unit. The related background information is encoded onto the test tube from a keyboard on the marking unit. Special handling instructions e. g., diagnostic test requests) may also be encoded onto the tube from the keyboard or from a previously prepared card which contains the instructions in machine readable form and which is inserted into the marking unit. The same card or an auxiliary card may also receive all or part of the information transcribed onto the sample container for subsequent correlation with the container.

Once the label is complete and the specimen drawn, the tube (and additional card if used) are delivered to the processing laboratory. The sample container can then be keyed into a device which decodes the marks previously transcribed onto the tube and transfers the identification and other information into storage in a data processing system. Satellite reading units can be employed for operator verification of paachieve the desired tient identity at any stage of the processing. The same or similar reading and previously mentioned writing units can be combined to form a transfer unit which automatically transcribes and reverifies the coded information from the original sample container to another test tube, a procedure which can be employed simultaneously with the automatic or manual transfer of part or all of the sample from one tube to another.

Numerous other features, objects and advantages of the invention will become apparent from the following specification when read in connection with the accompanying drawing in which:

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a block diagram illustrating the logical flow of elements into a portable label encoder according to the invention;

FIG. 2 is a perspective view of a suitable label encoder according to the invention;

FIG. 2 A is a bottom view of test tube 15.

FIG. 3 is a perspective view of a suitable test tube reader according to the invention; and

FIG. 4 is a block diagram illustrating the logical fiow of elements into a label transfer module.

DETAILED DESCRIPTION OF PREFERRE EMBODIMENTS With reference now to the drawing and more particularly FIG. 1 thereof, there is shown a portable label encoder 11 which may receive a test tube at input 12, a patient identification card at input 13 and a test request card at input 14 for encoding identification and other data on the test tube label 16 and preferably for simultaneous transcribing information on to the request card 24 concerning the tests to be made on the specimen. In an alternate embodiment a wrist bracelet may be read in a hand held unit connected to label encoder 11 by cable.

Referring to FIG. 2 there is shown a perspective exploded view of an exemplary embodiment of the portable label encoder 11. Test tube input 12 may include the circular opening with alignment pin 37 at the bottom so that test tube 15 with its label 16 and alignment indent 38 is keyed in position with the label 16 (best seen in FIG. 3) facing label encoder 17 to insure correct labeling of test tube 15. Vacutainer tubes adapted in manufacture to include this indent have been used to alignment. Test tube 15 preferably contains a permanent label in a well-defined orientation relative to the indent that is temperature sensitive so that label encoder 17 may appropriately encode with controlled heating elements the test tube label 16 with information such as patient identification, and other pertinent data such as the specimen type, the test to be performed, the ward, the time, the date and an accession number which also identified the particular portable label encoder 11. Temperature sensitive label 16 is preferably affixed to test tube 15 with a high melting point transparent plasticized adhesive tape which permanently bonds label 16 onto test tube 15, protects label 16 from spillage and other hazards, and facilitates the encoding of uniform marks on label 16 by diffusing the heat from the heating elements in label encoder 17. A preferred combination of materials uses an under layer of the Nashua Corporations OWT thermal sensitive paper beneath a self-adhering layer of the Connecticut Hard Rubber Company's KAPTON type 250 teflon tape. An alternate approach uses a thermosensitive paint such as one of the Tempil Corporation's TEMP- ALARM series which is applied directly to the tube by brush, spray, or dip and subsequently covered by a similarly applied protective and sealing overcoat. The label marks are imprinted by exposure to a set of multitum coils of nichrome wire whose temperature is elevated for a controlled time interval by a current source and time delay relay. The coil construction, exposure time, and operating temperature are adjusted to optimize the size and uniformity of the marks.

A patient identification card 21 may be inserted into input recess 13 so that the apparatus may read patient I. D. card 21 and actuate label encoder l7 accordingly to record this information on test tube label 16. Similarly, information such as the ward, date, time and accession number may be encoded on label 16 by label encoder 17 along with test requests that may be designated by the selection keys 18. In an alternate embodiment, the test request information could be read from card 24 rather than via the keyboard if such a card has been previously prepared elsewhere in the hospital system. The specific logical apparatus for reading the I. D. card may be any of the well-known card reader systems and is not a part of this invention.

Preferably the portable label encoder 11 includes a label verifier scanner 22 in recess 23 so that test tube may be placed in recess 23, and appropriate scanning mechanism actuated to effect readout of the permanent label identifying all the information on the label 16 to insure no error. The readout of these results may be on an associated CRT display, printed out or otherwise suitably displayed. The specific means for displaying the label information may be any well-known technique and is not a part of this invention.

Referring to FIG. 3, there is shown a perspective view of a suitable mechanism for effecting scanning of permanent label 16 of test tube 15. The unit reads the marks using reflected light. The linear array of marks is read in serial fashion as the read head is mechanically scanned along the tube. An alternate embodiment would employ an array of sensors, one for each mark to produce parallel read out. Label 16 is shown with two rows of binary data that may be optically read.

Scanner 22 resides in slot 23. A rack and pinion scanner 25 driven by a motor (not shown) causes the two rows 26 and 27 to be scanned by means including fiber optical cords 31 and 32, respectively, each energized at an input end 33 and 34, respectively, by a suitable light source (not shown) and delivering data representative light energy at output ends 35 and 36, respectively, to respective photocells (not shown) whose outputs may be suitably decoded by well known logical apparatus and converted into alphanumeric data corresponding to that imprinted upon label 24 by label encoder 17. Similar scanning apparatus and logical apparatus may be used at the input to individual test instruments to recover the identification information encoded on the label and correlate this information with the results of the analytical procedure on the specimen in the test tube 15. In addition such reading apparatus can be used to recover the information encoded on the test tube for visual display in the laboratory or elsewhere using a CRT, printer or other well known technique.

To facilitate the maintenance of absolute sample identity through normal laboratory processes such as the separation of cellular and fluid components by centrifugation and the division of the sample into numerous aliquots for a large number of discreteanalytic channels the above described reading and writing methods may be readily combined in a transfer module in which both the appropriate specimen component and the identification information are simultaneously transferred to a new test tube. The transcribed data is then automatically read and verified as in the bedside unit. The logical flow of material through this unit is shown in FIG. 4. The physical positioning of all test tubes within the transfer module may be performed either manually or automatically with the label transcription fully automated in the same fashion as in the bedside label marking unit, with the exception that the identification information is obtained from the original test tube instead of a card.

There has been described novel apparatus and techniques for insuring proper association of a specimen with a patient and the test to be performed on that patient. The invention is especially useful in connection with automatic testing and reporting systems using digital data techniques.

It is evident that those skilled in the art may now make numerous uses and modifications of any departures from the specific embodiments described herein without departing from the inventive concepts. Consequently, the invention is to be construed as embracing each and every novel feature and novel combination of features present in or possessed by the apparatus and techniques herein disclosed.

What is claimed is:

l. A method of medical data processing which method includes the steps of,

placing a specimen from a patient in a specimen container having a permanently attached encodable label thereon, placing said container in a code impressing means, then impressing encoded patient identification data from a patient identification means associated with and uniquely identifying said patient upon said encodable label to provide on said label an automatically readable identification of the patient from whom said specimen was taken, and

immediately after said impressing step and before said specimen is subjected to testing, placing said container in a code reading means associated with said code impressing means, scanning said encodable label to read out all the information encoded thereon and comparing the information thus read out with said patient identification data just previously impressed to insure the absence of error.

2. A method of medical data processing in accordance with claim 1 and further including the step of impressing encoded data on said label identifying the test to be performed upon said specimen to also provide on said label an automatically readable identification of the test to be performed upon said specimen.

3. A method of medical data processing in accordance with claim 2 and further including,

the scanning of said label being with said code reading means to provide an encoded output signal that both identifies said patient and the test to be performed upon said specimen.

4. Medical data processing apparatus comprising,

a specimen container having a permanently attached encodable label thereon,

patient identification means for providing encoded patient identification data uniquely identifying an associated patient, means for receiving both said specimen container and said patient identification means and responding to said patient identification means for impressing said encoded patient identification data upon said encodable label to provide on said label an automatically readable identification of the patient from whom the specimen in said container was taken,

said means for receiving also including separate means for receiving said specimen container for scanning said encodable label immediately after impressing encoded data by said means for impressing for reading out all the information encoded on said encodable label to provide an output indication for comparison with said patient identification data to insure the absence of error.

5. Medical data processing apparatus in accordance with claim 4 wherein said means for receiving includes means for impressing encoded data on said label identifying the test to be performed upon said specimen to also provide on said label an automatically readable identification of the test to be performed upon said specimen.

6. Medical data processing apparatus in accordance with claim 4 wherein said label includes thermosensitive material, and

said means for impressing includes means for selectively heating predetermined portions of said thermosensitive pizterial to visibly impress said encoded data upon said 7. Medical data processing apparatus in accordance with claim 6 wherein said thermosensitive material is secured to said container with a high melting point transparent plasticized adhesive tape.

8. Medical data processing apparatus in accordance with claim 6 wherein said therrnosensitive material is applied directly to said container as a layer of paint which is then covered by a suitable layer of protective and sealing material. 

1. A method of medical data processing which method includes the steps of, placing a specimen from a patient in a specimen container having a permanently attached encodable label thereon, placing said container in a code impressing means, then impressing encoded patient identification data from a patient identification means associated with and uniquely identifying said patient upon said encodable label to provide on said label an automatically readable identification of the patient from whom said specimen was taken, and immediately after said impressing step and before said specimen is subjected to testing, placing said container in a code reading means associated with said code impressing means, scanning said encodable label to read out all the information encoded thereon and comparing the information thus read out with said patient identification data just previously impressed to insure the absence of error.
 2. A method of medical data processing in accordance with claim 1 and further including the step of impressing encoded data on said label identifying the test to be performed upon said specimen to also provide on said label an automatically readable identification of the test to be performed upon said specimen.
 3. A method of medical data processing in accordance with claim 2 and further including, the scanning of said label being with said code reading means to provide an encoded output signal that both identifies said patient and the test to be performed upon said specimen.
 4. Medical data processing apparatus comprising, a specimen container having a permanently attached encodable label thereon, patient identification means for providing encoded patient identification data uniquely identifying an associated patient, means for receiving both said specimen container and said patient idenTification means and responding to said patient identification means for impressing said encoded patient identification data upon said encodable label to provide on said label an automatically readable identification of the patient from whom the specimen in said container was taken, said means for receiving also including separate means for receiving said specimen container for scanning said encodable label immediately after impressing encoded data by said means for impressing for reading out all the information encoded on said encodable label to provide an output indication for comparison with said patient identification data to insure the absence of error.
 5. Medical data processing apparatus in accordance with claim 4 wherein said means for receiving includes means for impressing encoded data on said label identifying the test to be performed upon said specimen to also provide on said label an automatically readable identification of the test to be performed upon said specimen.
 6. Medical data processing apparatus in accordance with claim 4 wherein said label includes thermosensitive material, and said means for impressing includes means for selectively heating predetermined portions of said thermosensitive material to visibly impress said encoded data upon said label.
 7. Medical data processing apparatus in accordance with claim 6 wherein said thermosensitive material is secured to said container with a high melting point transparent plasticized adhesive tape.
 8. Medical data processing apparatus in accordance with claim 6 wherein said thermosensitive material is applied directly to said container as a layer of paint which is then covered by a suitable layer of protective and sealing material. 